CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
June 2021—Qiagen received emergency use authorization for its QIAreach Anti-SARS-CoV-2 Total Test, a digital assay to detect total SARS-CoV-2 antibodies (IgA, IgG, IgM).
The serological test has been shown to have a sensitivity of 93.85 percent (confidence interval [CI], 84.99–98.30 percent) and a specificity of 97.83 percent (CI, 95.00–99.29 percent). The test was developed in partnership with Ellume and uses the digital eHub and eStick system. One QIAreach eHub can handle up to eight samples on eight eSticks simultaneously, with each eStick test running independently. Up to 32 samples can be processed in one hour, and results are available in about 10 minutes.
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